Zylet vs TobraDex in Blepharokeratoconjunctivitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00447577 |
Recruitment Status :
Completed
First Posted : March 14, 2007
Last Update Posted : December 9, 2011
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Condition or disease | Intervention/treatment | Phase |
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Blepharokeratoconjunctivitis | Drug: Loteprednol etabonate and tobramycin ophthalmic suspension Drug: Tobramycin and dexamethasone ophthalmic suspension | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 276 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension) in the Treatment of Blepharokeratoconjunctivitis |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2007 |

Arm | Intervention/treatment |
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Experimental: Zylet
Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)
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Drug: Loteprednol etabonate and tobramycin ophthalmic suspension
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days. |
Active Comparator: Tobradex
Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.
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Drug: Tobramycin and dexamethasone ophthalmic suspension
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days. |
- The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score [ Time Frame: 15 days ]
- The distribution of Investigator global assessment at each visit. [ Time Frame: Visit 2, 3 & 4 ]
- The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment. [ Time Frame: Visit 2, 3 & 4 ]
- The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score. [ Time Frame: Visit 2 & 3 ]
- The change from baseline to each visit in the signs composite score and the symptoms composite score. [ Time Frame: Visit 1, 2, 3 & 4 ]
- The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score. [ Time Frame: Visit 1, 2, 3 & 4 ]
- The change from baseline to each visit in individual signs and symptoms. [ Time Frame: Visit 1, 2, 3 & 4 ]
- VA, Biomicroscopy, and IOP assessments at each visit [ Time Frame: Visit 1, 2, 3 & 4 ]
- Adverse Events [ Time Frame: Visit 1, 2, 3 & 4 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must be at least 18 years of age
- Must be able and willing to comply with all treatment and follow up procedures
- Must have the ability to understand and sign an Informed Consent Form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization
- Must be able to self-administer drugs
- Must have a clinical diagnosis of blepharokeratoconjunctivitis in at least one eye (total Ocular Signs and Symptoms score of at least 10, with at least one ocular sign and one ocular symptom each having a score of Grade 2 level or higher)
- Women of childbearing potential must be sexually inactive or using an approved birth control methods and must have a negative urine pregnancy test
- Must be willing to discontinue contact lens use for the duration of the study
- Must have pin-holed Snellen visual acuity equal to or better than 20/40 in both eyes
Exclusion Criteria:
- Any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis)
- Known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids
- Use of any systemic or topical ophthalmic non-steroidal anti-inflammatory agents, analgesics, and antihistamines that cannot be discontinued during the study
- Use of any topical ophthalmic medications, including tear substitutes, within 2 hours before and that cannot be discontinued during the study
- Use of any systemic or topical ophthalmic antibiotic agents within 72 hours before and that cannot be discontinued during the study
- Use of any systemic or topical ophthalmic corticosteroid agents within 7 days before and that cannot be discontinued during the study
- Use of any systemic or topical ophthalmic mast cell stabilizers within 14 days before and that cannot be discontinued during the study
- Use of any topical ophthalmic immunosuppressant (e.g. Restasis) agents within 30 days before and that cannot be discontinued during the study
- Suspected preseptal cellulites, or any other disease conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug
- Suspected dacrocystitis
- Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
- Ocular surgery (including laser surgery) in either eye within the past 3 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447577
United States, North Carolina | |
Cornerstone Eye Care | |
High Point, North Carolina, United States, 27262 |
Study Director: | Timothy Comstock, OD | Bausch & Lomb Incorporated |
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT00447577 |
Other Study ID Numbers: |
512 |
First Posted: | March 14, 2007 Key Record Dates |
Last Update Posted: | December 9, 2011 |
Last Verified: | December 2011 |
Loteprednol Etabonate Tobramycin Dexamethasone Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Anti-Bacterial Agents Anti-Infective Agents Anti-Allergic Agents |